SUMMARY
The Senior R&D Engineer is responsible for the design and development of new and improved products and procedures that address vascular diseases and conditions using minimally invasive techniques.
PRINCIPAL DUTIES AND RESPONSIBILITIES
- Design, prototype and develop novel design solutions for catheter-based products to improve performance and ease of use in clinical procedures.
- Work as part of a cross-functional team to develop and evaluate product designs through verification and validation testing
- Prepare technical documentation, including manufacturing instructions, test methods, protocols, and reports to support design control activities and regulatory submissions
- Provide periodic updates regarding project status
- Contribute to the company’s intellectual property via invention disclosures, brainstorming sessions, and prototypes to demonstrate reduction to practice
- Interact with physicians regarding product development, testing, and product demonstrations
- Train other team members on product assembly; troubleshoot assembly process issues
- Maintain Design Control activities for new product development from initial concept through commercialization. These activities may include the following: developing product specifications, performing robust design evaluation, creating risk analyses, meeting goals for design reviews, and setting & executing design verification and validation strategies.
- Work collaboratively with other company functions as needed, including R&D, Marketing, Operations, Quality, Clinical and Regulatory to ensure project success.
- Support the development and upkeep of the Company’s Quality System in conjunction with the Company’s Quality Department.
EXPERIENCE REQUIREMENTS
- At least 5 years’ experience leading development of disposable medical device products.
- Experience with design and process development of medical device catheters.
- Experience with FDA and ISO standards for medical device design controls and manufacturing
EDUCATION REQUIREMENTS
BS Engineering (Mechanical or Biomedical)
OTHER QUALIFICATIONS
- Working knowledge of common catheter materials and construction methods.
- Successful track record of developing medical disposable products from conceptualization through product launch
- Self-motivated with ability to work independently and with minimal supervision
